510(k) Report

Devices descending from K050971

10 later devices reach Biovalve Insulin Delivery Systems (Bids) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100504V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40Valeritas, LLC20102—
+1K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.20106—
+2K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20241—
+2K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc.20124—
+2K103825V-GO Insulin Delivery SystemValeritas, Inc.201115
+2K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc.20105—
+3K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20260—
+3K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20242—
+3K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation20230—
+3K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH20173—